High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia

NCT07399301 | Not Yet Recruiting

• 1 other identifier: 202663
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sixty patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah. Patients will be assigned into two equal groups randomly: Group(A):N= 30 Patients in this group will receive high-intensity functional training exercises 3 times per week for 10 weeks. The initial duration of each session was 30 min, and it could be increased progressively, along with the intensity of the exercises, up to 50 min. All sessions included the following: i. 5 min warm-up ii. 40 min functional training exercises. iii. 5 min cool-down. Group (B): N=30 Patients in this group will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.

Conditions

Geriatric Sarcopenia

Keywords

HIGH- INTENSITY FUNCTIONAL TRAINING- PHYSICAL PERFORMANCE - MENTAL HEALTH - ELDERLY - SARCOPENIA

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB) test

  The SPPB assesses physical performance through balance, strength, and gait measurements and is made up of a set of three tests: standing static balance ; lower limb strength and power through getting up and sitting on a chair; and walking speed at normal pace. Strength and gait are first evaluated by the ability to perform the tasks of getting up and sitting on a chair five times and performing the walking speed test (3 to 4 meters) and, second, by the time the individual takes to complete the tasks. The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance).

  10 weeks

Secondary Outcomes (6)

• Hand Dynamometer

  10 weeks

• Quadriceps strength test

  10 weeks

• Montreal Cognitive Assessment

  10 weeks

• The Katz Index

  10 weeks

• The Geriatric Depression Scale-15 (GDS-15)

  10 weeks

Study Arms (2)

high-intensity functional training exercises

EXPERIMENTAL

A) Awarm up: for 5 min, B) Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study I. Sit to stand( Chair squats) II. Wall push up: III. Overhead triceps extension: IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min slow continuation of the activity.

Other: High-Intenisity Functional Training

sham therapy

SHAM COMPARATOR

Group (B): N=30 Patients in this group who will be found to have sarcopenia will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.Sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants

Other: Sham

Interventions

High-Intenisity Functional Training OTHER

A) Awarm up: for 5 min.warm-up (predominantly stretching) of the neck, shoulders, lower back, hips, knees and ankles. B) Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study. I. Sit to stand( Chair squats) II. Wall push up III. Overhead triceps extension IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min slow continuation of the activity, allows a more gradual reduction in heart rate and increased peripheral vascular resistance, with return of blood flow from the periphery Farmer's Carry training

high-intensity functional training exercises

Sham OTHER

The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants.

sham therapy

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Old individuals who will be found to have sarcopenia as defined according to European Working Group on Sarcopenia in Older People (EWGSOP2) 2019 criteria, The EWGSOP2 defines sarcopenia as a muscle disease characterized by progressive and generalized loss of skeletal muscle mass and function. Diagnosis requires sequential assessment of three components
• Low Muscle Strength: The primary criterion. Measured by:
• Handgrip strength: Cut-offs are \<27 kg for men and \<16 kg for women using a dynamometer.
• Chair Stand Test: ≥15 seconds for five rises indicates weakness.
• Low Muscle Quantity or Quality: Assessed via:
• o calf circumference (≤34 cm men, ≤33 cm women).
• Poor Physical Performance: Indicates severe sarcopenia. Tests include:
• Gait speed: ≤0.8 m/s over 4 meters.
• Short Physical Performance Battery (SPPB): ≤8 points.
• Timed Up-and-Go (TUG): ≥20 seconds.
• Age from 60 to 70 years old.
• Old individuals who will be found to have mild depression.

You may not qualify if:

• Neurological disorders.
• Vestibular or balance disorders.
• Uncontrolled hypertension or heart diseases.
• Recent surgeries or fractures.
• Any psychological disorders.
• Severe renal failure (glomerular filtration rate \< 30 mL/min).
• moderate to severe liver failure.
• The patients cannot follow instructions.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 12613, Egypt

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Research Ethical Committee Faculty of Physical Therapy - Cairo University

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Ethical Committee Faculty of Physical Therapy - Cairo University

CONTACT

01151312322; eth.com@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy Specialist at Damanhur Medical National Institute, EL-Behira, Egypt

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

EG (1)